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FDA 510(k) Application Details - K001013
Device Classification Name
Standard Polysomnograph With Electroencephalograph
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510(K) Number
K001013
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY 14228 US
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Contact
PETER WEISENBORN
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
03/29/2000
Decision Date
05/16/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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